IL TEST D-DIMER— 510(k) K972696

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K972696 for IL TEST D-DIMER, Substantially Equivalent on 1997-11-04. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1997-07-18
Decision date: 1997-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.